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JM-010 for Parkinson's Disease Dyskinesia (SHINE Trial)

Phase 2

Waitlist Available

Research Sponsored by Bukwang Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has more than one hour of "ON" time with troublesome dyskinesia

Has stable peak-effect dyskinesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

SHINE Trial Summary

This trial is testing a new drug for Parkinson's Disease. It is double-blind, meaning neither the patients nor the doctors know who is receiving the drug or the placebo. It is randomized, meaning patients are assigned by chance to either receive the drug or the placebo. And it is multicenter, meaning it is taking place at multiple medical centers.

Who is the study for?

This trial is for Parkinson's Disease patients aged 18-85 who experience dyskinesia, specifically those with stable peak-effect dyskinesia and over an hour of 'ON' time with troublesome symptoms. Participants must understand the study and consent to it. Those who've had PD surgery, substance use disorders, acute psychotic disorders, or require seizure treatment are excluded.Check my eligibility

What is being tested?

The study tests JM-010 in various combinations against a placebo in a two-part process. It's double-blind (neither researchers nor participants know who gets what), randomized (participants are randomly assigned treatments), and involves multiple centers.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones may include nausea, dizziness, sleep disturbances or mood changes due to the nature of Parkinson’s treatments. The trial will monitor for any adverse reactions.

SHINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience uncontrollable movements for over an hour daily.

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My involuntary movements are consistent and manageable.

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I have experienced involuntary muscle movements.

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I am between 18 and 85 years old.

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I have been diagnosed with Parkinson's disease according to UK standards.

SHINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Unified Dyskinesia Rating Scale (UDysRS)

Secondary outcome measures

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

SHINE Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2, JM-010 component Group CExperimental Treatment1 Intervention

Part 2, JM-010 component Group C

Group II: Part 2, JM-010 combination Group BExperimental Treatment1 Intervention

Part 2, JM-010 combination Group B

Group III: Part 2, JM-010 combination Group AExperimental Treatment1 Intervention

Part 2, JM-010 combination Group A

Group IV: Part 1, JM-010 component Group CExperimental Treatment1 Intervention

Part 1, JM-010 component Group C

Group V: Part 1, JM-010 component Group BExperimental Treatment1 Intervention

Part 1, JM-010 component Group B

Group VI: Part 1, JM-010 component Group AExperimental Treatment1 Intervention

Part 1, JM-010 component Group A

Group VII: Part 2, Placebo GroupPlacebo Group1 Intervention

Part 2, Placebo Group

Group VIII: Part 1, Placebo GroupPlacebo Group1 Intervention

Part 1, Placebo Group

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bukwang PharmaceuticalLead Sponsor

34 Previous Clinical Trials

2,698 Total Patients Enrolled

Bongju KwonStudy DirectorBukwang Pharmaceutical

Sooyeon ParkStudy DirectorBukwang Pharmaceutical

Media Library

JM-010 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04377945 — Phase 2

Parkinson's Disease Research Study Groups: Part 2, JM-010 component Group C, Part 2, Placebo Group, Part 1, Placebo Group, Part 1, JM-010 component Group A, Part 1, JM-010 component Group B, Part 2, JM-010 combination Group B, Part 1, JM-010 component Group C, Part 2, JM-010 combination Group A

Parkinson's Disease Clinical Trial 2023: JM-010 Highlights & Side Effects. Trial Name: NCT04377945 — Phase 2

JM-010 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04377945 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA okayed JM-010 Part 2, Group B as an official combination therapy?

"There is early evidence supporting the safety of Part 2, JM-010 combination Group B, which received a score of 2."

Answered by AI

Are investigators currently looking for new participants in this trial?

"Yes, this is an ongoing study that is looking for more participants. The clinical trial was posted on 4/28/2021 and updated most recently on 3/21/2022 according to the website clinicaltrials.gov"

Answered by AI

Does this clinical trial have an age limit? If so, what is it?

"According to the rules that determine who can and cannot participate in this clinical trial, the minimum age is 18 and the maximum age is 80."

Answered by AI

How many people are enrolled in this research project?

"The clinical trial is currently admitting 188 patients between 2 sites, as stated on clinicaltrials.gov. The site was first posted on 4/28/2021 and updated most recently on 3/21/2022."

Answered by AI

Who would best fit the profile of an ideal candidate for this experiment?

"This study is currently recruiting 188 participants that have a diagnosis of idiopathic PD which meets the UK Parkinson's disease Society (UKPDS) criteria. To be eligible, patients must also experience dyskinesia and have stable peak-effect dyskinesia. Lastly, candidates must have more than one hour of "ON" time with troublesome dyskinesia each day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components

2021. "Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04377945.

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